Source: Les Echos

Gilead renounces reimbursement of its antiviral against Covid-19 in France. The High Authority for Health considers that the medical service for remdesivir is weak and that access to reimbursement is not justified to treat the most severe forms of the disease. However, patients can continue to be administered it.

Truth beyond the Atlantic, error on this side. While in the United States, Donald Trump has won more than 90% of the stock of remdesivir to treat coronavirus patients in his country, showing his faith in the remedy, the reception is much more mixed in France. Moreover, the antiviral from the American laboratory Gilead will ultimately not be supported in France for severe forms of Covid-19. The manufacturer has decided to withdraw its request for access to reimbursement, the High Authority for Health announced on Thursday.

“The HAS takes note of the withdrawal from the laboratory, even before its hearing and despite a favorable opinion for registration for reimbursement in certain indications” , writes the High Authority in a press release. Gilead apparently decided to back down after learning about the draft opinion of the HAS Transparency Committee, which evaluated the drug this summer. The treatment is billed at 2,081 euros in developed countries, a fairly high price.

“It should be noted that, although remdesivir is eligible for an economic evaluation, the Economic and Public Health Evaluation Commission (CEESP) was unable to assess its efficiency in the claimed indication because the laboratory did not provide data, ” adds the HAS. The question of the cost / benefit ratio will therefore not be answered immediately.

However, French patients will be able to continue to be treated with remdesivir – like Silvio Berlusconi, who has just been released from hospital in Italy. The European Commission has in fact bought a stock of remedesivir, which it delivers to the countries most affected by the epidemic, free of charge. France has received thousands of vials since this summer, much more than the hundred cases treated under the temporary authorization for use granted on July 2.

No overall effect on 14-day mortality

Remdesivir, initially designed to fight Ebola, received conditional marketing authorization in Europe in early July, two months after authorization on the American market, for severe forms of Covid-19. However, the HAS judges that in the most serious cases, that is to say pneumonia requiring high flow oxygen, oxygen plus ventilation, oxygenation by extracorporeal membrane, “no clinical benefit” has only been “suggested” .

The only case that could justify access to reimbursement: patients aged 12 or over and weighing at least 40 kilos, receiving low flow oxygen. “The actual benefit is considered low,” writes the HAS, which mentions “an overall reduction of 4 days in the patient’s clinical recovery time (11 days instead of 15) compared to placebo”. “Remdesivir does not at this stage show an overall effect on 14-day mortality ,  she continues.

“The HAS does its job as if it were a conventional drug, while remdesivir was developed on an emergency basis in five months. It is impossible to put together a complete medico-economic file so quickly”, pleads Michel Joly, the president of Gilead France. “We have set the price so that it is less than four days of hospitalization: our treatment has therefore already demonstrated its effectiveness for the health system”, he argues. Some 1,500 hospital beds would have been released in France if the use of remdesivir had been generalized at the start of the epidemic, Gilead calculated.

In the field, hospital doctors have resorted more and more to corticosteroids, widespread and inexpensive, after seeing an improvement in the state of health of their patients. The World Health Organization and the High Council for Public Health recommend it. On the other hand, no antiviral has yet proved its worth.





Related:

The war on Hydroxychloroquine can be traced back to Gilead, the drug maker looking to profit big from Remdesivir

France: Natural history of COVID-19 and therapeutic options (hydroxychloroquine, azithromycin and zinc may represent the best current theraputic option)

FRANCE: EFFECT OF HYDROXYCHLOROQUINE WITH OR WITHOUT AZITHROMYCIN ON THE MORTALITY OF COVID-19 PATIENTS: A SYSTEMATIC REVIEW AND META-ANALYSIS

Hydroxychloroquine and azithromycin tolerance in haemodialysis patients during COVID-19 infection

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